Status:
UNKNOWN
Kidney Precision Medicine Project (KPMP) - COVID-19 Protocol
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Conditions:
Acute Kidney Failure
Acute Kidney Insufficiency
Eligibility:
All Genders
18+ years
Brief Summary
Since its inception, KPMP has developed sophisticated protocols for collection and analysis of human kidney tissue, and for collection of biofluids. Members of the consortium have wide-ranging experti...
Detailed Description
The COVID-19 pandemic has drastically altered life globally and killed thousands since its emergence in December of 2019. Unfortunately, the global toll will only continue to increase. Sars-CoV-2, the...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older admitted to participating hospitals with a positive COVID-19 test result or Persons Under Investigation with suspected COVID-19 infection AND with AKI or at high risk of AKI in the setting of COVID-19 infection, as defined by any ONE of the following:
- pre-existing chronic kidney disease as defined by eGFR less than 60 ml/min/1.73 m2
- history of diabetes mellitus established by at least one of the following criteria:
- Hemoglobin A1C greater than or equal to 6.5%, confirmed with a repeat test within the past year
- Fasting blood sugar greater than or equal to 126 mg/dL, confirmed with a repeat test within the past year
- Use of glucose-lowering therapy (insulin or oral or other subcutaneous agents)
- International Classification of Diseases (ICD) 9/10 diagnostic code for diabetes
- requiring use of vasopressors
- requiring use of mechanical ventilation
- AKI is defined by temporal changes in serum creatinine meeting KDIGO Stage 1 criteria or greater (0.3 rise in serum creatinine over baseline value). If a baseline serum creatinine is not available, the patient can be enrolled with an estimated Baseline serum creatinine (see KPMP COVID-19 Manual of Procedures table 1)
- Exclusion Criteria:
- Any potential participant meeting any one of the general or safety exclusion criteria will not be eligible for enrollment in the KPMP COVID-19 Substudy. Exclusion criteria include non-transient conditions that would not allow for enrollment in the main KPMP study.
- Determined at time of Eligibility Assessment prior to consent:
- Non-English or Spanish language
- Less than 18 years of age
- Severe allergy to iodinated contrast
- Transplant recipient (kidney or non-kidney, including solid organ and bone marrow transplantation)
- Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study)
- Inability to provide informed consent or obtain surrogate consent from a legally authorized representative (LAR)
- Unwilling to receive blood transfusion (if needed)
- Baseline eGFR less than 15 ml/min/m2
- If known at the time of enrollment, or determined by kidney ultrasound before the biopsy procedure (may be the same day as the biopsy procedure)
- Kidney size less than 8 cm (percutaneous biopsies only)
- Solitary or single functioning kidney
- Evidence of urinary tract obstruction or hydronephrosis
- Multiple bilateral kidney cysts
Exclusion
Key Trial Info
Start Date :
June 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05384899
Start Date
June 15 2021
End Date
October 30 2022
Last Update
May 20 2022
Active Locations (4)
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1
Yale University
New Haven, Connecticut, United States, 06520
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 48374
4
University of Texas at Southwestern
Dallas, Texas, United States, 75390